Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression

Research on Efficacy and Safety of Robot-assisted rTMS Based on Neuroimaging Navigation for the Treatment of Depressive Patients With Suicidal Ideation

There is relatively insufficient evidence on whether rTMS can improve suicidal ideation in depressive patients. And existing studies have been inconsistent in the treatment of depressive suicidal thoughts. The possible reason is inaccurate stimuli localization. Improving the accuracy of rTMS stimulus positioning may further improve the intervention effect of suicidal ideation. This study will introduce an automated TMS system with robot control and optical sensor combined with neuronavigation softwarea. By using the robot based on neuronavigation system, the rTMS coil can be accurately positioned over any preselected brain region. An infrared optical measurement device is also used in order to detect and compensate for head movements of the patient. The purpose of this randomized double-blind and sham-controlled study is to test the efficacy and safety of robot-assisted rTMS based on neuronavigation in the treatment of depressive suicidal ideation.

Study Overview

• Status: Recruiting
• Conditions: Depression; Suicidal Ideation
• Intervention / Treatment: Combination product: Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Combination product: Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Combination product: Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: NaiLong TANG; Phone Number: +8618960692506; Email: tangfmmu@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • XijingH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-60 years
• meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
• have a score > 17 on the HAMD-17
• have a score ≥ 6 on the BSI-CV
• right- handedness
• physical examination, medical history, vital signs, blood routine, liver and kidney function, ECG, EEG and other indicators are normal
• are voluntary and competent to consent to treatment

Exclusion Criteria:

• People with a history of severe physical illness and depression caused by psychoactive substances and non-dependent substances
• Patients with metal or electronic equipment, such as intracranial metal foreign bodies, cochlear implants, pacemakers and brace, etc.
• Risk of seizures, previous central nervous system diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or family history of epilepsy
• Acute suicide
• have psychotic symptoms and need to use antipsychotic drugs
• receive ECT treatment within 2 months
• pregnant, breastfeeding or planning to become pregnant during the trial
• refuses to sign the consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted accelerated iTBS-1800 and Antidepressants; MDD patients with suicidal ideation will receive antidepressants combined with robot-assisted accelerated iTBS-1800(10 sessions per day over 5 consecutive days). This group is in order to determine the safety, tolerability and feasibility of accelerated iTBS protocol.	Combination product: Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Subjects will receive a 5-day trial of robot-assisted accelerated iTBS-1800 (10 sessions of iTBS1800 with 50 min interval per day over 5 consecutive days) combined with SNRIs（Venlafaxine or Duloxetine).
Active Comparator: Robot-assisted accelerated iTBS-600 and Antidepressants; MDD patients with suicidal ideation will receive antidepressants combined with robot-assisted accelerated iTBS-600(6 sessions of iTBS with 30 min interval per day over 5 consecutive days).	Combination product: Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Subjects will receive a 5-day trial of robot-assisted accelerated iTBS-600 (6 sessions of iTBS600 with 30 min interval per day over 5 consecutive days) combined with SNRIs（Venlafaxine or Duloxetine）
Sham Comparator: Sham accelerated iTBS-600 and Antidepressants; MDD patients with suicidal ideation and depression will receive antidepressants combined with sham accelerated iTBS-600(6 sessions of sham iTBS with 30 min interval per day over 5 consecutive days).	Combination product: Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Subjects will receive a 5-day trial of sham accelerated iTBS (6 sessions of iTBS600 with 30 min interval per day over 5 consecutive days) combined with SNRIs（Venlafaxine or Duloxetine）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score	Outcome measured by a change in BSI-CV score from baseline to 4 weeks post-treatment. BSI-CV is a self-reported questionnaire with 19 items. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide.	Pre-treatment to immediately post treatment (on day 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score	Outcome measured by a change in HAMD-17 score from baseline to 4 weeks post-treatment.The HAMD Total Score comprises a sum of the 17 individual item scores. Each item is rated on a 3 point scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Response is defined as having a 50% or greater reduction from baseline in HAMD total score. Remission is defined as having a HAMD total score of ≤7.	Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score	Outcome measured by a change in MADRS score from baseline to 4 weeks post-treatment. The MADRS is a 10-item, clinician-rated questionnaire used to evaluate the severity of depression. Each item is rated on a scale from 0-6.4,5 Scores are then summed to yield a total score ranging from 0 (none/absent) to 60 (most severe).	Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Change in the Beck Depression Inventory (BDI)	Outcome measured by a change in BDI score from baseline to 4 weeks post-treatment. The BDI-II is a 21-item, self-rated scale that assesses the severity of depressive symptoms.Items are rated according to severity on a 0-3 scale, with the exception of two items rated on a 0-6 scale.The BDI is scored by simple addition and has a maximum total score of 63 .Higher total scores indicate more severe depressive symptoms.	Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Change in the 6-Item Hamilton Rating Scale for Depression (HAMD-6) Score	HAMD-6 is a shorter version of the HAMD-17 scale which measures only depressed mood (item 1), feeling of guilt (item 2), work and activities (item 7), motor retardation (item 8), psychic anxiety (item 10), and somatic symptoms (general) (item 13). Higher total scores indicate more severe depressive symptoms.	Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging (MRI)	resting-state functional MRI	Baseline, Within 2 days post-treatment
near-infrared imaging technology (fNIRS)	task-state fNIRS	Baseline, Within 2 days post-treatment

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: HuaNing WANG, PhD, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: November 28, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Depression; rTMS; Suicidal Ideation; Neuronavigation; robot-assisted rTMS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Self-Injurious Behavior; Suicide; Depression; Depressive Disorder; Suicidal Ideation; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Serotonin Receptor Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine; Serotonin; Serotonin and Noradrenaline Reuptake Inhibitors
• Other Study ID Numbers: KY20202066-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No